A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALKS 5461

• Registration Number: NCT02521857
• Lead Sponsor: Alkermes, Inc.

Brief Summary

This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
• Is in good physical health
• Agrees to use an approved method of contraception for the duration of the study
• Additional criteria may apply

Exclusion Criteria

• Is currently pregnant or breastfeeding
• Has a history of substance abuse disorder
• Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
• Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
• Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
• Has used alcohol within 72 hours prior to any inpatient period
• Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
• Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
• Additional criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 5461	ALKS 5461	Sublingual tablet

Primary Outcome Measures

Name	Time	Method
AUClast	Up to 72 hours	Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461
AUCinf	Up to 72 hours	Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461
Cmax	Up to 72 hours	Maximum observed plasma concentration for ALKS 5461

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability will be measured by the incidence of Adverse Effects	Up to 46 days

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States